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Devices Oncology Reimbursement

 News Release - December 21, 2018

BTG Announces National Reimbursement for TheraSphere(R) in France

An estimated 500 patients per year in France could be eligible for treatment with TheraSphere®

LONDON, December 21, 2018 -- (Healthcare Sales & Marketing Network) -- BTG plc (LSE: BTG), a global specialist healthcare company, today announced that the French Ministry of Health and Social Affairs will reimburse TheraSphere® for patients with liver cancer who meet certain criteria.

TheraSphere® will be included on the medical device reimbursement list (Liste des Produits et Prestations et Remboursés) for the treatment of patients with hepatocellular cancer classed as BCLC[i] B or C disease, with portal vein thrombosis (PVT), with an ECOG[ii] status of 0-1, Child-Pugh[iii] A or B and who are intolerant to, or have progressed on, sorafenib. It is estimated that up to 500 patients per year could be eligible for treatment.

"This reimbursement decision provides access to a new treatment option for some of the estimated 9,600 people diagnosed with liver cancer in France each year[iv]," said Jane Lapon, VP Global Market Access at BTG. "TheraSphere® is a powerful, targeted and well-tolerated therapy and in some cases can lead to patients becoming eligible for curative therapies. BTG continues to pursue reimbursement and improved access to TheraSphere® for liver cancer patients around the world."

TheraSphere® will be reimbursed for a 5-year period, during which BTG will collect data on all patients treated in France. This data will be used to support renewal of the reimbursement after the 5-year period.

The Ministry of Health's decision follows the positive opinion reached by the Commission Nationale d'Evaluation des Dispositifs Medicaux et des Technologies de Santé (CNEDiMTS) in February 2018, recognising that TheraSphere® showed clinical benefit in this patient population compared to best supportive care (ASA IV).

About TheraSphere®

TheraSphere® is a targeted therapy that consists of millions of glass microspheres containing radioactive yttrium-90. The microspheres are delivered directly to liver tumours through the hepatic artery via catheter and become permanently lodged there. Because the procedure delivers the treatment directly to the liver tumour, the radiation destroys the tumour cells with minimal impact to the surrounding healthy liver tissue. The microspheres continue to deliver radiation to the tumour over the course of several weeks after treatment. Over 20,000 patients worldwide have been treated with TheraSphere®.

For full instructions for use and important safety information, please visit http://www.therasphere.com.

About BTG Interventional Oncology

BTG Interventional Oncology is committed to transforming the way cancer is treated with our portfolio of minimally-invasive, highly targeted cancer therapies that can be personalised to each patient's needs. Our products are used to treat or provide symptomatic relief for people with cancer and benign tumours. To learn more about BTG Interventional Oncology, please follow @BTGIO on twitter or visit: http://www.btg-io.com

References:

i. Barcelona Clinic Liver Cancer (BCLC) is a system for staging liver cancer based on the number and size of tumours.

ii. Eastern Cooperative Oncology Group (ECOG) is a scale used assess how a patient's disease is progressing and how the disease affects the daily living abilities of the patient.

iii. Child-Pugh scores describe the clinical state of patients with cirrhosis of the liver or chronic liver disease.

iv. INVS. Projection de l'incidence et de la mortalité par cancer en France métropolitaine en 2015. Rapport technique. Novembre 2015


Source: BTG

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